Wockhardt gets US FDA nod for generic anti-bacterial drug
Wockhardt says it has received approval from the US FDA to market generic version of Wyeth’s Zosyn, used for treating bacterial infections, in the American market
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New Delhi: Drug firm Wockhardt has received approval from the US health regulator to market generic version of Wyeth’s Zosyn, used for treating bacterial infections, in the American market.
The application for the product to the US Food and Drug Administration (USFDA) was made by the company’s subsidiary Wockhardt Bio AG, the Mumbai-based company said in a regulatory filing.
“Wockhardt Bio AG had filed this abbreviated new drug application (ANDA) in collaboration with Fresinius Kabi, Italy (FKAI) where the product development was completed,” it added.
The ANDA will be manufactured commercially at FKAI, Mitim, Italy, it said. Wockhardt stock closed 2.54% down at Rs727.60 on BSE.